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Re: enemem post# 15061

Thursday, 01/24/2008 5:16:41 PM

Thursday, January 24, 2008 5:16:41 PM

Post# of 51453
Even if the FDA's response to the Vioxx issue--a drug marketed to millions--could have reasonably been extrapolated to mean trouble for a new drug even going into Phase I (the obvious conclusion was that new drugs would face problems with their NDA's--I don't know anyone in the industry who thought it would so permeate the system that IND's would get messed up).....even if that could have been predicted to be problematic, I have a hard time imagining not trying to get it through, given that an OK would have meant a partnership for ADHD. Unless they were 100% sure of an IND-rejection, and I think it's impossible to conclude that there was any evidence of any such certainty, they really were obligated to try to get it through. There was no precedent that would have predicted IND failure....until Cortex.

IF they HADN'T tried to get that ADHD IND through, even if their chances were less than 50/50: that to me would have been reason to call for resignations. They took their shot, as they were obligated to do, given the potential pay-off.

Addendum: An analogy. Two climbers and a Sherpa are within 300 feet of the summit of Mt Everest. The winds are picking up, and a couple of climbers come down from above saying it's getting difficult. The climbers ask the Sherpa what he thinks they should do. The Sherpa says they might make it, might not, impossible to know.

Question: Do the climbers decide to quit, climb back down, and go climb another mountain instead, one which they know less about than Everest?

NeuroInvestment


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